Ignite Creation Date:
2024-05-06 @ 2:17 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04276675
Status:
COMPLETED
Last Update Posted:
2023-09-15
First Post:
2020-02-11
Brief Title:
CR Developing an Intervention to Improve Acceptance of Referral in HF
Sponsor:
University of Leicester
Organization:
University of Leicester
Study Overview
Official Title:
Cardiac Rehabilitation Programme in Patients Following Hospitalisation for Decompensated Chronic Heart Failure the Development of an Intervention to Improve Patient Acceptance of Referral
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CREATE-HF
Brief Summary:
Background There are proven benefits to people with chronic heart failure CHF participating in a cardiac rehabilitation CR programme however uptake remains disappointingly low Admission to hospital presents a significant opportunity to offer CR referral to such a patient population It is believed that up to 75 of patients with CHF show signs of frailty at discharge which might impact on the rate of patients acceptance of referral to CR
Aim To explore the impact of frailty on patient acceptance of referral to CR following admission to hospital with an episode of decompensated CHF
Methods and expected outcome We will conduct an observational study assessing the relationship between frailty and acceptance of referral to CR in this patient population It will also explore what factors impact that relationship including demographic factors measures of self-care and patient activation measure PAM
Aim To explore the impact of frailty on patient acceptance of referral to CR following admission to hospital with an episode of decompensated CHF
Methods and expected outcome We will conduct an observational study assessing the relationship between frailty and acceptance of referral to CR in this patient population It will also explore what factors impact that relationship including demographic factors measures of self-care and patient activation measure PAM
Detailed Description:
Trial Design Mixed method approach to development of an intervention observational cohort study semi-structured interviews focus groups staff survey theory informed intervention development using The Behaviour Change Wheel
Trial Participants
1 Patients admitted to hospital for an episode of decompensated heart failure who have been referred to the Heart Failure Nursing Service HFNS and are eligible for referral for cardiac rehabilitation
2 Patients who have been referred to cardiac rehabilitation from the HFNS Cardiology outpatients and general practice
3 Health care professionals involved in the referral to or provision of cardiac rehabilitation services for people with chronic heart failure
Planned Sample Size
203 patients in observational study 8 to 40 participants in semi-structured interviews10 to 15 health care professionals in focus groups 40 health care professionals questionnaire
Follow-up duration
Part 1 of the study Observational Cohort from discharge to 6 weeks post discharge Part 2 of the study Semi-structured interviews participants have single semi-structured interview and given the opportunity to feedback on final proposed intervention Focus groups cardiac rehabilitation team health care professionals participate in one focus group and feedback on final proposed intervention Part 3 of study Health care professional single participation in survey and subgroup of HCP feedback on final proposed intervention
Planned Trial Period 24 months including feasibility study of intervention
Primary Objective The primary objective of this study is to determine the key modifiable patient related factors associated with the acceptance of referral to cardiac rehabilitation in patients post discharge following an episode of decompensated chronic heart failure
Secondary Objectives Using the Behaviour Change wheel synthesize the data from the observational study stakeholder perspectives and the literature on behaviour change interventions develop a theory based intervention to increase the uptake of referral to cardiac rehabilitation in patients post discharge following an episode of decompensated chronic heart failure
Primary Endpoint
Observational study Uptake of referral to cardiac rehabilitation by patients following an episode of decompensated heart failure at baseline visit
Semi-structured interviews focus groups and staff survey Identify patient and health care professional perceived barriers and facilitators to the uptake of referral to cardiac rehabilitation by patients following an episode of decompensated heart failure
Secondary Endpoints
Observational study Uptake of referral to cardiac rehabilitation by patients following an episode of decompensated heart failure at 6 weeks post discharge
Semi-structured interviews focus groups and staff survey Identify the impact of COVID 19 pandemic on the uptake of referral and participation in cardiac rehabilitation by patients following an episode of decompensated heart failure
In consultation with experts in theory based interventions data from all steps of the programme of study will be used to develop an intervention aimed at improving rate of acceptance of referral to CR in this patient population
Further stakeholder involvement The intervention will be presented back in written form to interviewees and focus group members for further comment either written or via telephone contact Health care professionals HFNS team and CR team will be invited for feedback on expected effectiveness and acceptability following which further adaptation of the intervention may occur
Trial Participants
1 Patients admitted to hospital for an episode of decompensated heart failure who have been referred to the Heart Failure Nursing Service HFNS and are eligible for referral for cardiac rehabilitation
2 Patients who have been referred to cardiac rehabilitation from the HFNS Cardiology outpatients and general practice
3 Health care professionals involved in the referral to or provision of cardiac rehabilitation services for people with chronic heart failure
Planned Sample Size
203 patients in observational study 8 to 40 participants in semi-structured interviews10 to 15 health care professionals in focus groups 40 health care professionals questionnaire
Follow-up duration
Part 1 of the study Observational Cohort from discharge to 6 weeks post discharge Part 2 of the study Semi-structured interviews participants have single semi-structured interview and given the opportunity to feedback on final proposed intervention Focus groups cardiac rehabilitation team health care professionals participate in one focus group and feedback on final proposed intervention Part 3 of study Health care professional single participation in survey and subgroup of HCP feedback on final proposed intervention
Planned Trial Period 24 months including feasibility study of intervention
Primary Objective The primary objective of this study is to determine the key modifiable patient related factors associated with the acceptance of referral to cardiac rehabilitation in patients post discharge following an episode of decompensated chronic heart failure
Secondary Objectives Using the Behaviour Change wheel synthesize the data from the observational study stakeholder perspectives and the literature on behaviour change interventions develop a theory based intervention to increase the uptake of referral to cardiac rehabilitation in patients post discharge following an episode of decompensated chronic heart failure
Primary Endpoint
Observational study Uptake of referral to cardiac rehabilitation by patients following an episode of decompensated heart failure at baseline visit
Semi-structured interviews focus groups and staff survey Identify patient and health care professional perceived barriers and facilitators to the uptake of referral to cardiac rehabilitation by patients following an episode of decompensated heart failure
Secondary Endpoints
Observational study Uptake of referral to cardiac rehabilitation by patients following an episode of decompensated heart failure at 6 weeks post discharge
Semi-structured interviews focus groups and staff survey Identify the impact of COVID 19 pandemic on the uptake of referral and participation in cardiac rehabilitation by patients following an episode of decompensated heart failure
In consultation with experts in theory based interventions data from all steps of the programme of study will be used to develop an intervention aimed at improving rate of acceptance of referral to CR in this patient population
Further stakeholder involvement The intervention will be presented back in written form to interviewees and focus group members for further comment either written or via telephone contact Health care professionals HFNS team and CR team will be invited for feedback on expected effectiveness and acceptability following which further adaptation of the intervention may occur
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None